NIH-funded research R01 grant

Carefully weighing medications during pregnancy in autoimmune diseases

Official title: Comprehensive Assessment of medication Risk-bEnefit in autoimmune disease for Healthy Pregnancies (CARE-HP)

Funded at Harvard Pilgrim Health Care, INC. · NIH-11449460 · Data updated 2026-11-12

This project examines how advanced autoimmune medications taken by pregnant people with autoimmune diseases affect both mother and baby.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionHarvard Pilgrim Health Care, INC.
NIH-funded
Lab location1 site (Canton, UNITED STATES)
Project startSeptember 2, 2026
Project endJune 30, 2031
Funding year2026
Award (this year)$703,092
NIH project number1R01HD123733-01A1
Project IDNIH-11449460 on NIH RePORTER

Who could benefit from this research

Could help

People with autoimmune diseases who are pregnant or planning pregnancy and who are using or considering advanced therapies like biologics or JAK inhibitors.

Less likely to help

Pregnant individuals with autoimmune conditions not receiving advanced therapies or not contributing data to large-scale analyses may not directly benefit.

What this research studies

Pregnant people with autoimmune diseases often need powerful medicines, but we don’t know enough about how these drugs affect pregnancy outcomes. The project will analyze large health data to compare many possible outcomes when these treatments are continued, started, or stopped during pregnancy. By combining data mining with follow-up studies, researchers aim to reveal patterns that help clinicians balance benefits and risks for mother and child. The work builds on prior methods to provide clearer, evidence-based guidance for pregnancy protection and fetal health in autoimmune conditions.

Why it matters

Potential benefit: If successful, it could lead to clearer guidance on which autoimmune medications are safest and most effective during pregnancy, improving outcomes for both mothers and babies.

How similar studies have gone: Previous observational studies offer limited insights, and this project aims to broaden understanding using massive data and scalable analyses, which is a novel extension with potential for strong impact.

Where this research is happening

  • Harvard Pilgrim Health Care, INC.
    Canton, United States
    Active

Researchers

  • Principal investigator: Maro, Judith — Harvard Pilgrim Health Care, INC.
  • Study coordinator: Maro, Judith

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.